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K Number
K041433
Device Name
BRIGHT GOLD XH
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2004-08-19

(83 days)

Product Code
EJS
Regulation Number
872.3060
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Brite Gold XH alloy intended to be used for onlays, % crowns, crowns and short span bridges PFM crowns

Device Description

Bright Gold

AI/ML Overview

I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental alloy named "Bright Gold xh" (and later corrected to "Brite Gold XH").

The letter states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device has been found to be as safe and effective as a device already on the market, but it does not include details about specific performance acceptance criteria or a study demonstrating that the device meets those criteria.

The document primarily focuses on:

  • The device name and regulation details.
  • The FDA's finding of substantial equivalence.
  • Regulatory requirements and responsibilities for the manufacturer.
  • The intended indications for use (onlays, ¾ crowns, crowns, short span bridges, PFM crowns).

It does not contain the specific information requested in your prompt regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance of a test set.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication method for a test set.
  5. MRMC comparative effectiveness study results.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for a training set.
  9. How ground truth for the training set was established.

These kinds of details would typically be found in the premarket notification submission itself (which is not provided here) or in a separate study report, not in the FDA's clearance letter.

§ 872.3060 Noble metal alloy.

(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.